EpiCept seeks FDA Fast Track designation for AmiKet to treat CIPN
Comments (0)Posts tagged: designation
Comments (0)EMA grants Orphan Drug Designation to Ceptaris’ chlormethine gel for treatment of CTCL
Ceptaris Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Ceptaris' investigational drug, chlormethine gel, for the treatment of Cutaneous T-Cell Lymphoma.
ceptaris, chlormethine, ctcl, designation, drug, ema, gel, grants, orphan, treatment
FDA grants orphan designation for AMT’s hemophilia gene therapy program
Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today that the U.S. Food and Drug Administration has granted orphan drug designation to its gene therapy program for the treatment of hemophilia B.
amts, designation, fda, gene, grants, hemophilia, orphan, program, therapy
Tufts professor receives IEEE Fellow designation
Eric Miller, professor of electrical and computer engineering in the School of Engineering at Tufts University, has been elected a fellow by the Institute for Electrical and Electronics Engineers.
Celladon Corporation Receives FDA Fast Track Designation For Its Investigational Agent MYDICAR® For The Treatment Of Heart Failure
Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced that its investigational product candidate MYDICAR® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced heart failure. The Fast Track program of ...
Onyx receives FDA Standard Review designation for carfilzomib NDA to treat RRMM
Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Standard Review designation to the New Drug Application (NDA) for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma.
carfilzomib, designation, fda, nda, onyx, receives, review, rrmm, standard, treat
FDA assigns priority-review designation for ELIQUIS NDA for stroke prevention in atrial fibrillation
Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for ELIQUIS® (apixaban), an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
assigns, atrial, designation, eliquis, fda, fibrillation, nda, prevention, priority, review, stroke
EMA recommends 4SC’s resminostat for orphan medicinal product designation to treat HL
4SC AG, a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, today announced that the European Medicines Agency (EMA) has recommended 4SC's anti-cancer compound resminostat for designation as orphan medicinal product for the treatment of Hodgkin's Lymphoma (HL), a cancer of the lymphatic system.
Liver Cancer Drug Provectus Receives Orphan Drug Designation From FDA
The U.S. Food and Drug Administration (FDA) has given orphan drug designation to Provectus Pharmaceuticals, Inc., for Rose Bengal, the active component in their new oncology medication PV-10. The drug is designed for the treatment of hepatocellular carcinoma (HCC), the most prevalent form of liver cancer. At present Provectus is ...
FDA grants orphan drug designation for Avedro’s VibeX to treat Keratoconus
Avedro, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company's VibeX for use with its KXL System (UVA irradiation) for Corneal Cross-linking to treat Keratoconus.
avedros, designation, drug, fda, grants, keratoconus, orphan, treat, vibex
FDA Grants Fast Track Designation For Alpharadin For Castration Resistant Prostate Cancer In Patients With Bone Metastases
Investigational drug Alpharadin (radium-223 chloride) for the treatment of castration-resistant prostate cancer in patients whose cancer has spread to the bone (bone metastasis) has been granted Fast Track designation by the FDA (Food and Drug Administration), Bayer Health Care announced today. Alpharadin is exclusively licenced to Bayer from Algeta ASA. ...
alpharadin, bone, cancer, castration, designation, fast, fda, grants, metastases, patients, prostate, resistant, track
KRN5500 For Chemotherapy-Induced Neuropathic Pain In Cancer Patients Gets Fast Track Designation By FDA, USA
According to today's announcement by DARA BioSciences, Inc., the U.S. Food and Drug Administration (FDA) granted a fast track designation to for their investigational drug KRN5500 for the treatment of chemotherapy-induced neuropathic pain in cancer patients. DARA's KRN5500 achieved positive results in its Phase II clinical trial (DTCL100), ...
cancer, chemotherapy, designation, fast, fda, induced, krn5500, neuropathic, pain, patients, track, usa